ClearPoint System (Software Version 2.2)

510(k)K233243NeurologyHAW

ClearPoint Neuro Inc. is listed for ClearPoint System (Software Version 2.2) (K233243). The FDA list gives November 27, 2023 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is HAW. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233243

Official FDA database record

Date of final decision: November 27, 2023
Company on the FDA list: ClearPoint Neuro Inc.
Lead panel: Neurology
Primary product code: HAW
openFDA device name for the code: Neurological Stereotaxic Instrument
Device class: 2
Regulation number: 882.4560
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary